#853594
—(1) Ní bheidh sé dleathach do dhuine dar deonadh ceadúnas déantóra aon tsubstaint íce le n-a mbaineann an tAcht so do dhéanamh, chun a díolta, mara mbeidh an tsubstaint íce sin do réir na gcaighdeán nirt, cáile agus íodhaine a bheidh orduithe maidir leis an substaint íce sin leis na rialacháin i dtaobh caighdeán substaintí íce.
—(1) It shall not be lawful for a person to whom a manufacturer's licence has been granted to manufacture for sale any therapeutic substance to which this Act applies unless such therapeutic substance complies with the standards of strength, quality and purity prescribed in respect of such therapeutic substance by the regulations as to the standards of therapeutic substances.